Axcella is a biotechnology company that has developed a new system of treating complex diseases. Its lead candidates are products that treat two liver diseases, as well as NASH, which is fatty inflammation of the liver (nonalcoholic steatohepatitis).
Biospace recently featured details of Axcella’s posters that were presented at the virtual Annual 2020 Liver Meeting® held in November.
Abstract 1663 in the presentation describes a sixteen-week study of people with NAFLD (nonalcoholic fatty liver disease) and Type 2 Diabetes. Participants who received AXA1125 saw reductions in metabolism markers and fibroinflammation.
ALT, a liver enzyme that is involved with the metabolism of proteins in the body, was also reduced during the sixteen-week trial period.
Abstract 1694 in the trial describes a sixteen-week study of the tolerability and safety of AXA1125 and AXA1957. Participants were diagnosed with NAFLD either with or without Type 2 Diabetes. Reductions were seen in subjects who received AXA1125 in fasting glucose, insulin, and measures of fibroinflammation in the liver, among other measures.
Results of the Study
Data was presented from the AXA1125-003 clinical trial with an enrollment of 102 participants assuming the existence of NASH either with or without Type 2 Diabetes. AXA1125 and AXA1957 were assessed over sixteen weeks for tolerability, safety, and effects on liver functions.
NAFLD, also associated with cirrhosis and fibrosis, is yet another multifactorial disease, such as NASH, that would benefit from methods such as fibroinflammatory and metabolic pathways.
Results of the study showed reductions in metabolism in participants receiving AXA1125 compared to the placebo. There was also a decrease in ALT, a liver enzyme that increases in the blood when the liver is damaged.
A larger proportion of participants receiving AXA1125 versus a placebo met clinical thresholds.
Advances in Network Biology
A patient’s metabolism can often be regulated by amino acids or other molecules. Doctors may use metabolic activity to assess the patient’s prognosis and determine the appropriate treatment.
Treatment for multifactorial (more than one genetic factor) diseases generally requires the patient to take more than one medication. This increases the risk of drug interactions and other adverse events.
The underlying aspects of multifactorial diseases create a challenge when attempting to determine the appropriate treatment. But recent advances in network biology brought opportunities for the design of a single therapy to treat multifactorial diseases.
Amino acids as well as precursor metabolites (intermediate molecules) are endogenous metabolic modulators with varied biological functions. In disease, amino acids and molecules often regulate metabolism. This metabolic activity enables the assessment of disease treatment and disease prognosis.
Looking Forward
Axcella plans a Phase 2b trial for 2021 involving patients with NASH that is proven via a biopsy. The company is confident that its NASH therapy will be beneficial to patients with type 2 diabetes.
